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Anamorelin Hydrochloride, Physical Activity, and Nutritional Counseling in Decreasing Cancer-Related Fatigue in Patients With Incurable Metastatic or Recurrent Solid Tumors

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ClinicalTrials.gov Identifier: NCT03035409
Recruitment Status : Active, not recruiting
First Posted : January 30, 2017
Last Update Posted : May 22, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This phase II trial studies how well anamorelin hydrochloride, physical activity, and nutritional counseling work in decreasing cancer-related fatigue in patients with incurable solid tumors that have spread to other parts of the body or have come back. Anamorelin hydrochloride, physical activity, and nutritional counseling may help to decrease cancer-related fatigue in patients with solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Malignant Solid Neoplasm C-Reactive Protein Measurement Cancer Fatigue Metastatic Malignant Solid Neoplasm Recurrent Malignant Solid Neoplasm Weight Loss Drug: Anamorelin Hydrochloride Behavioral: Exercise Intervention Other: Laboratory Biomarker Analysis Other: Nutritional Assessment Other: Quality-of-Life Assessment Other: Questionnaire Administration Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate changes in the Functional Assessment of Cancer Illness Therapy-Fatigue (FACIT-F) subscale score at day 43 +/- 3 days compared to baseline in patients with advanced cancer receiving oral anamorelin hydrochloride (anamorelin) 100 mg daily and standardized physical activity and nutritional counseling.

SECONDARY OBJECTIVES:

I. To examine the effects of anamorelin and standardized physical activity and nutritional counseling on health-related quality of life and patient reported outcomes as measured by the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), Patient Reported Outcomes Measurement Information System (PROMIS) - Fatigue, Hospital Anxiety Depression Scale (HADS), Edmonton Symptom Assessment Scale (ESAS), Functional Assessment of Cancer Therapy (FACT-G) and its Functional Assessment of Anorexia/Cachexia Treatment (FAACT) subscale in these patients.

II. To examine the side effects and tolerability of anamorelin in these patients.

EXPLORATORY OBJECTIVES:

I. To explore the effects of anamorelin and standardized physical activity and nutritional counseling on muscle function (as measured by the 30 second chair stand test, 6 minute walk test, day time activity [accelerometer], body composition [as measured by INBODY], and resting energy expenditure [measured by indirect calorimetry]).

II. To characterize the effects of anamorelin on potential inflammatory biomarkers of cancer-related fatigue (CRF) (C-Reactive Protein [CRP], monocyte IL-6&R, TNF-a&R, IL-10, IL-8, IL-1&RA; IGF-1).

III. To explore the effects of anamorelin on sleep as measured by the Pittsburgh Sleep Quality Index (PSQI).

IV. To determine the association between change in FACIT-F scores and changes in muscle function, day time activity, and body composition, in patients with advanced cancer receiving oral anamorelin 100 mg daily and standardized physical activity and nutritional counseling.

OUTLINE:

Patients receive anamorelin hydrochloride orally (PO) once daily (QD) and undergo physical activity consisting of resistance exercises and a home walking program. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo nutritional counseling on day 21.

After completion of study treatment, patients are followed up on day 71.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Anamorelin on Cancer-Related-Fatigue in Patients With Advanced Cancer
Actual Study Start Date : February 8, 2017
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supportive Care (anamorelin, physical activity, counseling)
Patients receive anamorelin hydrochloride PO QD and undergo physical activity consisting of resistance exercises and a home walking program. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo nutritional counseling on day 21.
Drug: Anamorelin Hydrochloride
Given PO
Other Name: RC-1291 HCl

Behavioral: Exercise Intervention
Undergo physical activity

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Nutritional Assessment
Undergo nutritional counseling
Other Names:
  • Dietary Assessment
  • dietary counseling
  • nutritional counseling

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Change in Functional Assessment of Cancer Illness Therapy-Fatigue subscale score [ Time Frame: Baseline up to day 43 ]
    Mean, standard deviation, median, and range for continuous variables, frequency and proportion for categorical variables will be calculated. Will determine mean change in Functional Assessment of Cancer Illness Therapy-Fatigue subscale.


Secondary Outcome Measures :
  1. Change in quality of life [ Time Frame: Baseline up to day 43 ]
    Measured by Multidimensional Fatigue Symptom Inventory-Short Form, Patient Reported Outcomes Measurement Information System-fatigue, Functional Assessment of Cancer Therapy, Functional Assessment of Anorexia/Cachexia Treatment, Edmonton Symptom Assessment Scale symptoms, Hospital Anxiety Depression Scale, Godin leisure time physical activity questionnaire, Pittsburgh Sleep Quality Index, and Global Symptom Evaluation scores questionnaires. Mean, standard deviation, median, and range for continuous variables, frequency and proportion for categorical variables will be calculated.

  2. Frequency and type of side effects [ Time Frame: Up to day 43 ]
    Assessed by National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.0

  3. Change in muscle function as measured by the 30 second chair stand test and 6 minute walk test [ Time Frame: Baseline up to day 43 ]
    Will also examine the association between change in Functional Assessment of Cancer Illness Therapy-Fatigue scores and changes in muscle function using correlation coefficients.

  4. Change in day time activity as measured by accelerometer [ Time Frame: Baseline up to day 43 ]
    Will also examine the association between change in Functional Assessment of Cancer Illness Therapy-Fatigue scores and changes in day time activity using correlation coefficients.

  5. Change in body composition as measured by INBODY [ Time Frame: Baseline up to day 43 ]
    Will also examine the association between change in Functional Assessment of Cancer Illness Therapy-Fatigue scores and changes in body composition using correlation coefficients.

  6. Change in resting energy expenditure as measured by indirect calorimetry [ Time Frame: Baseline up to day 43 ]
    Will also examine the association between change in Functional Assessment of Cancer Illness Therapy-Fatigue scores and changes in body composition using correlation coefficients.


Other Outcome Measures:
  1. Inflammatory response of cytokines, c-reactive protein, and IGF-1 [ Time Frame: Up to day 43 ]
    Based on whether the data will be normally distributed (Shapiro-Wilk test), will use paired t-test or non-parametric equivalents.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with a diagnosis of advanced cancer (metastatic or recurrent incurable solid tumors excluding prostate cancer)
  • Presence of fatigue on FACIT-F subscale of =< 34 on a 0 to 52 scale (in which 52 = no fatigue and 0 = worst possible fatigue)
  • Patient should describe fatigue as being present for a minimum of 2 weeks prior to screening
  • CRP must be >= 3 mg/l in the absence of any other more likely cause of increased CRP like an infection or an autoimmune disorder
  • No evidence of moderate to severe depression as determined by a HADS depression score of =< 13
  • Presence of unintentional weight loss ranging from >= 2 - =< 15% in last 12 months
  • Uncontrolled pain; if patient is on opioids for the treatment of cancer pain, he/she must have had no major dose change (> 25%) for at least 48 hours prior to study entry; the dose of morphine equivalent daily should not exceed 120 mg/day unless approved by the principal investigator (PI); change in opioid dose after study entry is allowed
  • Patient must be willing to engage in telephone follow up with research staff
  • Patient must have telephone access to be contacted by the research staff
  • Hemoglobin level of >= 9 g/dL
  • Estimated life expectancy of > 4 months at the time of screening
  • Aspartate transaminase (AST) and alanine transaminase (ALT) levels =< 5 x upper limit of normal (ULN)

Exclusion Criteria:

  • Major contraindications to anamorelin e.g. hypersensitivity
  • Regularly engaged in moderate or vigorous-intensity exercise for at least 5 times a week
  • Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study
  • Pregnant or lactating women, childbearing age women who are not on birth control; negative pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and a history of menses within the last 12 months; pregnancy test to be performed no greater than 14 days prior to consent in study; in cases of women with elevated b-HCG, these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy; women of childbearing potential need to be on or use contraception, or be abstinent during the study period; their male partners must also use contraception (condom) or maintain abstinence; birth controls specifications: women who are able to become pregnant must use birth control during the study and for 30 days after the last anamorelin dose; acceptable forms of birth control include barrier methods (such as condom or diaphragm) with spermicide
  • Uncontrolled diabetes mellitus (fasting blood sugar > 200 mg/dl) at screening
  • Male patients with a history of untreated hypogonadism
  • Patients on drugs with strong CYP 3A4 inhibitors within the previous two weeks (ketoconazole, clarithromycin, itraconazole, nefazodone, telithromycin)
  • Patients on drugs that may prolong the PR or QRS interval durations, such as any of the class I/sodium (Na+) channel blocking antiarrhythmic medications should be avoided (e.g. flecainide, procainamide, propafenone, quinidine)
  • Patients with untreated clinically relevant hypothyroidism
  • Patients currently on investigational therapies will be evaluated by the PI on a case by case basis and study participation approval will be obtained from the treating oncologist
  • Patients with prostate cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035409


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Sriram Yennu M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03035409    
Other Study ID Numbers: 2016-0655
NCI-2017-00188 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0655 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Weight Loss
Fatigue
Neoplasms
Body Weight Changes
Body Weight
Signs and Symptoms